||1R03CA283105-01 Interpret this number
||University Of Michigan At Ann Arbor
||A Pilot Feasibility Study of an Intervention to Decrease Overtreatment of Low-Risk Thyroid Cancer
Nearly 90% of patients with low-risk papillary thyroid cancer undergo total thyroidectomy, the treatment option
with the greatest morbidity, even though less invasive options offer equivalent recurrence and survival.
Overtreatment of these patients results in significant patient harm and substantial costs. Currently, patients
have unmet informational needs that contribute to the uptake of total thyroidectomy. Patients with low-risk
papillary thyroid cancer would benefit from an intervention that meets their informational needs and increases
their ability to participate in the decision-making process. This proposal is a key step to support our longer-term
goal of reducing overtreatment of low-risk thyroid cancer by intervening on surgical decision making.
Our research team developed a novel intervention called CQUPLE, which includes (1) a Chart of side-by-side,
evidence-based information comparing all three management options for low-risk thyroid cancer, including
expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the
surgeon. The intervention is grounded in social cognitive theory and aims to increase patient awareness of
treatment options and their outcomes, patient activation, and self-efficacy for decision making. This proposal
will pilot CQUPLE at three clinic sites in a single health system. We propose a pilot feasibility randomized
controlled trial in 50 patients with low-risk papillary thyroid cancer to evaluate the feasibility and acceptability of
CQUPLE (Aim 1) and characterize the distribution of outcomes (Aim 2).
The results of the proposed research will provide the preliminary data necessary to prepare for a future, large-
scale pragmatic efficacy trial to test the effect of CQUPLE on patients’ choice for total thyroidectomy. CQUPLE
is a low-cost, scalable, patient-directed intervention that is innovative because it combines two complimentary
components that work to meet patients’ informational and decisional needs through different mechanisms. The
research is significant because reducing rates of total thyroidectomy for patients with low-risk thyroid cancer
has the potential to decrease patient harm and improve long-term outcomes. Our multidisciplinary team’s
history of successful collaboration and experience in behavioral intervention design and testing with
randomizes controlled trials make us well positioned to achieve the aims of this award.